1. Field of the Invention
The present invention relates generally to a device for attaching a first mass to a second mass and methods of making and using the same.
2. Description of the Related Art
Prosthetic heart valves can replace defective human valves in patients. Prosthetic valves commonly include sewing rings, suture cuffs or rings that are attached to and extend around the outer circumference of the prosthetic valve orifice.
In a typical prosthetic valve implantation procedure, the aorta is incised and the defective valve is removed leaving the desired placement site that may include a fibrous tissue layer or annular tissue. Known heart valve replacement techniques include individually passing sutures through the fibrous tissue or desired placement site within the valve annulus to form an array of sutures. Free ends of the sutures are extended out of the thoracic cavity and laid, spaced apart, on the patient's body. The free ends of the sutures are then individually threaded through a flange of the sewing ring. Once all sutures have been run through the sewing ring (typically 12 to 18 sutures), all the sutures are pulled up taught and the prosthetic valve is slid or “parachuted” down into place adjacent the placement site tissue. The prosthetic valve is then secured in place by traditional knot tying with the sutures. This procedure is time consuming as doctors often use three to ten knots per suture.
The sewing ring is often made of a biocompatible fabric through which a needle and suture can pass. The prosthetic valves are typically attached to the sewing rings which are sutured to a biological mass that is left when the surgeon removes the existing valve from the patient's heart. The sutures are tied snugly, thereby securing the sewing ring to the biological mass and, in turn, the prosthetic valve to the heart.
During heart valve replacement procedures, the patient is on heart-lung bypass which reduces the patient's oxygen level and creates non-physiological blood flow dynamics. The longer a patient is on heat-lung bypass, the greater the risk for permanent health damage. Existing suturing techniques extend the duration of bypass and increase the health risks due to heart-lung bypass. Furthermore, the fixturing force created by suturing varies significantly from suture to suture, even for the same medical professional.
In addition, sutures and other attachment devices are used in a variety of medical applications where the use of the device of the present invention would provide an advantage in fixing a first mass to a second mass, where the first mass is a tissue or a device or prosthesis, and the second mass is a tissue or a device or prosthesis. These applications include anchoring a prosthesis such as a synthetic or autologous graft to surrounding tissue or another prosthesis, tissue repair such as in the closure of congenital defects such as septal heart defects, tissue or vessel anastomosis, fixation of tissue with or without a reinforcing mesh for hernia repair, orthopedic anchoring such as in bone fusing or tendon or muscle repair, ophthalmic indications, laparoscopic or endoscopic tissue repair or placement of prostheses, or use by robotic devices for procedures performed remotely.
For these indications and others, there is a need for a fixturing device to minimize the time spent fixturing certain devices or conduits, such as a valve prosthesis and a second mass, a vessel to another vessel or anatomical structure, tissue to tissue, surrounding tissue to a second prosthesis, and the like as described above. Furthermore, there is a need for a device that compliments existing suturing or attachment devices and methods and reduces fixturing times. Also, there is a need for a fixturing device that can be easily removed. There also exist a need to provide a fixturing device that can provide a consistent fixturing force.